Hemostatic device

ABSTRACT

A hemostatic device includes a flexible band adapted to be wrapped around a patient&#39;s limb at a site on the limb where bleeding is to be stopped, a portion for securing the band in a wrapped state to the limb, a curved plate which is made of a material more rigid than the band and at least a portion of which is curved toward the inner peripheral side thereof, a main balloon which is provided on the inner peripheral side of the curved plate and which inflates when a fluid is introduced therein, and a pressing member which is provided between the curved plate and the main balloon so that at least a portion thereof overlaps with the balloon and which is adapted for pressing against the balloon. The device provides an excellent hemostatic effect and prevents numbness and poor circulation in areas peripheral to the site of attachment.

This application is a continuation of U.S. application Ser. No.13/889,112 filed on May 7, 2013, which is a continuation of U.S.application Ser. No. 12/356,969 filed on Jan. 21, 2009, which is adivisional application of U.S. application Ser. No. 10/618,964 filed onJul. 15, 2003, and claims priority to Japanese Application No.2002-206295 filed on Jul. 15, 2002, Japanese Application No. 2002-323940filed on Nov. 7, 2002 and Japanese Application No. 2002-373013 filed onDec. 24, 2002 the entire content of all of which is incorporated hereinby reference.

FIELD OF THE INVENTION

The present invention relates to a hemostatic device, and moreparticularly to a hemostatic device which is attached to a patient'slimb at a site on the limb where bleeding is to be stopped and which, bythe inflation of a balloon, applies pressure to the site so as to stopbleeding.

BACKGROUND DISCUSSION

When a procedure involving the percutaneous insertion of an instrumentsuch as a catheter into a blood vessel is carried out for medicaltreatment, examination or diagnosis, bleeding at the puncture site mustbe stopped following subsequent withdrawal and removal of the catheter.Hemostatic devices which are attached by being wrapped around theportion of an arm or leg where the puncture site is located and compressthe puncture site where bleeding is to be stopped are already known inthe prior art (e.g., JP 3031486 U).

In such prior-art hemostatic devices, the pressure applied to the sitewhere bleeding is to be stopped is directed in a substantiallyvertically downward direction, and the hemostatic effect in thispressing direction is inadequate. Therefore, complete hemostatissometimes does not occur or takes a long time to achieve.

Moreover, prior-art hemostatic devices apply pressure not only to thepuncture site where bleeding is to be stopped, but to the surroundingarea as well. Hence, other tissues are also compressed, including otherblood vessels and nerves, sometimes resulting in numbness and poor bloodcirculation.

To keep this from happening, a health care practitioner such as aphysician or nurse must lower the compressive force over time bycarrying out manual operations to reduce the balloon pressure or loosenthe band, which is inefficient and inconvenient.

In addition, when using such prior-art hemostatic devices, the healthcare practitioner visually sights the balloon into place over thepuncture site. It has been pointed out that this makes the balloondifficult to position properly. In fact, due to poor positioning of theballoon, a hematoma may form or blood leakage may occur because of theinability to stop bleeding.

SUMMARY

The hemostatic device disclosed here has an excellent hemostatic effect.

The hemostatic device disclosed here also spontaneously (that is,without manipulation by a health care practitioner such as a physicianor nurse—sometimes referred to hereinafter as the “operator”) eases overtime the pressure applied by the balloon, thus helping to preventharmful effects from the continued application of pressure, such asnumbness, pain and vascular blockage.

The disclosed hemostatic device enables a balloon for compressing apuncture site (a site where blood flow is to be stopped) to be easilypositioned at the site, and thus minimizes blood leakage and hematomaformation due to poor positioning of the balloon.

According to one aspect, a hemostatic device comprises: a flexible bandconfigured to be wrapped around a wrist of a patient at a site wherebleeding is to be stopped so that the flexible band is in a wrappedstate on the patient's wrist, a fastener to secure the flexible band inthe wrapped state around the patient's wrist, a curved plate defining aconcave curve along the inner surface, and a balloon positionablebetween the curved plate and the patient's wrist in the wrapped state ofthe flexible band. The balloon includes a center and is inflatable uponintroducing gas into the balloon when the flexible band is in thewrapped state with the balloon positioned between the patient's wristand the plate to apply a compressive force to the site where bleeding isto be stopped. A marker is located to position the center of the balloonat the site where bleeding is to be stopped. The band, the balloon andthe curved plate are fabricated from substantially transparent materialspermitting visualization of the site where bleeding is to be stoppedwhen the flexible band is in the wrapped state with the balloonpositioned between the patient's wrist and the curved plate. The balloonis made of a gas permeable material selected so that after the balloonis inflated by the gas, the gas in the balloon is gradually releasedthrough the gas permeable material to outside the balloon to graduallydecrease the compressive force applied to the site where bleeding is tobe stopped

According to another aspect, a hemostatic device includes a band made offlexible material allowing the band to be wrapped around a wrist of apatient at a site where bleeding is to be stopped so that the band is ina wrapped state on the patient's wrist, a fastener to secure theflexible band in the wrapped state around the patient's wrist, a platepossessing an inner surface and an outer surface, with at least aportion of the plate being curved so that the plate includes a curvedplate portion defining a concave curve along the inner surface of theplate that faces toward the patient when the band is in the wrappedstate, and a balloon positionable between the plate and the patient'swrist when the band is in the wrapped state. The balloon is inflatableupon introducing gas into the balloon when the band is in the wrappedstate with the balloon positioned between the patient's wrist and theplate to apply a compressive force to the site where bleeding is to bestopped. The band, the balloon and at least a part of the plate beingsubstantially transparent to permit visualization through the band, theplate and the balloon of the site where bleeding is to be stopped whenthe band is in the wrapped state with the balloon positioned between thepatient's wrist and the plate. The balloon is made of a material whichis permeable to the gas in the balloon after the gas is introduced intothe balloon to inflate the balloon and which is selected so that the gasin the balloon is gradually released through the gas permeable materialto outside the balloon to gradually decrease the compressive forceapplied to the site where bleeding is to be stopped.

A further aspect of the disclosure here involves a method to stopbleeding at a puncture site of an artery on a wrist of a patient. Themethod comprises wrapping a band of a hemostatic device around the wristof the patient, wherein the hemostatic device also includes a platehaving a portion which is curved, a balloon and a marker, with theflexible band, the curved plate and the balloon being substantiallytransparent. The wrapping of the band around the wrist of the patientcomprises wrapping the band around the wrist of the patient while theballoon is in an uninflated state so that the balloon is between theplate and the wrist of the patient. The method further includespositioning the balloon in overlying relation to the puncture site, withthe positioning of the balloon in overlying relation to the puncturesite being accomplished by visually observing the marker, introducingfluid into the balloon to increase internal pressure in the balloon andinflate the balloon to apply a compressive force to the puncture siteselected to stop bleeding at the puncture site; and after inflating theballoon to apply the compressive force to the puncture site to help stopbleeding at the puncture site, gradually decreasing the internalpressure in the balloon while maintaining the compressive force againstthe puncture site. The gradual decrease of the internal pressure in theballoon is performed without any manual operation.

These and other aspects, features and advantages of the hemostaticdevice and method disclosed here will become more apparent uponconsideration of the following detailed description and the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a bottom view of a first embodiment of the hemostatic deviceaccording to the invention. This shows the side of the device thatserves as the inside surface when the device is attached to the wrist ofa patient.

FIG. 2 is a sectional view showing the same hemostatic device as in FIG.1 during use.

FIG. 3 is a sectional view showing a second embodiment of the hemostaticdevice according to the invention.

FIG. 4 is a sectional view showing a third embodiment of the hemostaticdevice according to the invention.

FIG. 5 is a bottom view of a fourth embodiment of the hemostatic deviceaccording to the invention. This shows the side of the device thatserves as the inside surface when the device is attached to the wrist ofa patient.

FIG. 6 is a sectional view showing the same hemostatic device as in FIG.5 during use.

FIG. 7 is a graph of the change over time in balloon internal pressurein the examples of the invention and the comparative examples which aredescribed later in this specification.

DETAILED DESCRIPTION OF THE INVENTION First Embodiment

As noted above, FIG. 1 is a bottom view of a first embodiment of thehemostatic device according to the invention. This shows the side of thedevice that serves as the inside surface when the device is attached tothe wrist of a patient. FIG. 2 is a sectional view showing the samehemostatic device attached and in use on the wrist.

The hemostatic device 1 shown in FIGS. 1 and 2 is used to stop bleedingat a puncture site 510 following the removal of an instrument such as acatheter which was inserted percutaneously into an artery through apuncture formed somewhere on a limb, such as at a wrist 500, for amedical purpose such as treatment, examination or diagnosis. Thishemostatic device 1 has a band 2 which is adapted to be wrapped aroundthe wrist 500, a surface fastener 3 for securing the band 2 in a wrappedstate to the wrist 500, a curved plate 4, a main balloon 5 and asecondary balloon 6.

The band 2 is a flexible belt-like member. As shown in FIG. 2, the band2 is attached to the wrist 500 by being wrapped one full turn around theoutside of the wrist 500 and having portions of the band 2 near bothends thereof mutually overlap. The overlapping portions of the band 2are then secured, or joined, by means of the subsequently describedsurface fastener 3.

The material making up the band 2 is not subject to any particularlimitation, as far as the puncture site 510 can be seen therethrough.Illustrative examples include polyvinyl chloride, polyolefins such aspolyethylene, polypropylene, polybutadiene and ethylene-vinyl acetatecopolymers (EVA), polyesters such as polyethylene terephthalate (PET)and polybutylene terephthalate (PBT), polyvinylidene chloride,silicones, polyurethanes various thermoplastic elastomers such aspolyamide elastomers, polyurethane elastomers and polyester elastomers,and any combinations of the above in the form of, for example, resinblends, polymer alloys or laminates.

It is preferable for the band 2 to be substantially transparent toensure that the puncture site 510 is visible therethrough.

The material making up the band 2 is in the form of a sheet which may beof any suitable thickness. For the band 2 to have a tensile modulus andan elongation percentage within the subsequently described ranges, it ispreferable for the sheet-like material of which it is made to have athickness of about 0.1 to 0.5 mm, and especially about 0.2 to 0.3 mm.

The band 2 may have near the center thereof a curved plate holder 21 forholding the subsequently described curved plate 4. In the embodimentshown in FIG. 1, the curved plate holder 21 is composed in part of aseparate strip-like member joined to the outside (or inside) surface ofthe band 2 by a suitable method such as welding (e.g., heat welding,high-frequency welding, ultrasonic welding) or adhesion (such as with anadhesive or solvent) so as to form a double layer construction. Thecurved plate 4 is inserted into a gap in the double layer and therebyheld.

The band 2 has attached to it, on the inside surface (the front side inthe plane of FIG. 1) thereof near the left end in FIG. 1, the male side(or female side) 31 of a surface fastener 3 such as a velcro-type hookand loop fastener (e.g., the product commonly known in Japan as MagicTape®). Similarly, the band 2 has attached to it, on the outside surface(the back side in the plane of FIG. 1) near the right end in FIG. 1, thefemale side (or male side) 32 of a surface fastener 3. As shown in FIG.2, the band 2 is attached to the wrist 500 by joining together the maleside 31 and the female side 32 of this surface fastener 3. The meansthat may be employed to secure the band 2 in a wrapped state to thewrist 500 are not limited only to surface fasteners 3. Other suitablemeans include snaps, buttons, clips, and members such as buckles throughwhich the ends of the band 2 are passed.

The curved plate 4 is inserted into the gap in the double layerconstruction of the curved plate holder 21 on the band 2, and is therebyheld on the band 2.

The curved plate 4 is shaped so that at least a portion thereof iscurved toward an inner peripheral side of the plate 4. This curved plate4 is constructed of a material more rigid than the band 2 and maintainsa substantially fixed shape.

As is apparent from FIG. 1, in this embodiment, the curved plate 4 has ashape that is elongated in the lengthwise direction of the band 2. Asshown in FIG. 2, the curved plate 4 has a center portion 41 in thelengthwise direction thereof which is substantially uncurved and thusshaped as a flat plate. The curved plate 4 also has, on either side ofthis center portion 41, curved portions 42 which curve toward the innerperipheral side of the plate 4 and along the lengthwise direction of theband 2 (circumferential direction of the wrist 500). The curved portions42 have a radius of curvature R2 which is smaller than the radius ofcurvature R1 of the center portion 41 (in the illustrated arrangement,R1 is substantially infinite).

The material making up the curved plate 4 is not subject to anyparticular limitation, as far as the puncture site 510 can be seentherethrough. Examples of materials of which the curved plate 4 may bemade include acrylic resins, polyvinyl chloride (particularly rigidpolyvinyl chloride), polyolefins such as polyethylene, polypropylene andpolybutadiene, polystyrene, poly(4-methyl-1-pentene), polycarbonates,ABS resins, polymethyl methacrylate (PMMA), polyacetals, polyarylates,polyacrylonitriles, polyvinylidene fluorides, ionomers,acrylonitrile-butadiene-styrene copolymers, polyesters such aspolyethylene terephthalate (PET) and polybutylene terephthalate (PBT),butadiene-styrene copolymers, aromatic and aliphatic polyamides, andfluorocarbon resins such as polytetrafluoroethylene.

It is preferable for the curved plate 4 to be substantially transparentto ensure that the puncture site 510 is externally visible.

Alternatively, the curved plate 4 may have no uncurved portion such ascenter portion 41, and may thus be curved over its entire length.

The method of providing the curved plate 4 on the band 2 is not limitedto the illustrated arrangement, and may involve joining the curved plate4 to the inside surface or outside surface of the band 2 by a suitablemethod such as welding or adhesion. The band 2 need not encircle thewrist 500 completely. For example, another acceptable arrangement is onein which the band 2 is connected to both ends of the curved plate 4. Itis thus not essential for a portion of the band 2 to overlap with thecurved plate 4.

The band 2 or curved plate 4 has connected to the inner side thereof aballoon 5 made of a flexible material. The balloon 5 inflates when afluid (a gas such as air, or a liquid) is introduced therein, thusapplying pressure to the puncture site 510 on the wrist 500.

The balloon 5 is positioned near one end of the curved plate 4 in thelengthwise direction thereof. That is, in the arrangement shown in FIG.2, the balloon 5 is in a position that overlaps with substantially theright half of the curved plate 4.

The material making up the balloon 5 is not subject to any particularlimitation provided it is a material that allows the puncture site 510to be seen. For example, a material similar to that making up the band 2may be used. To facilitate joining of the balloon 5 with the band 2 bywelding, and thus make the hemostatic device 1 easier to manufacture, itis preferable for the balloon 5 to be made of a material which is of thesame nature or type as that making up the band 2.

It is desirable for the balloon 5 to be substantially transparent toensure that the puncture site is externally visible.

The material making up the balloon 5 is in the form of a sheet which maybe of any suitable thickness. For the balloon 5 to have a tensilemodulus and an elongation percentage within the subsequently describedranges, it is preferable for the sheet-like material of which it is madeto have a thickness of about 0.1 to 0.5 mm, and especially about 0.2 to0.3 mm.

The balloon 5 may have a construction in which the edges of sheets madeof the above-described material are sealed together by a suitableprocess such as welding or adhesion to form a sort of pouch. In thearrangement shown in FIG. 1, the balloon 5 is substantially square inthe uninflated state.

The balloon 5 is connected to the band 2 by a flexible connector 11. Inthe present embodiment, the balloon 5 is connected to the band 2 by aconnector 11 only on the side of one end of the curved plate 4; that is,only on the right side in FIG. 2. The connector 11 has a relativelyshort length, thereby keeping the balloon 5 tethered in a positiondeviated to one end of the curved plate 4. The connector 11 ispreferably made of the same material as the balloon 5.

In the present embodiment, because only one side of the balloon 5 isconnected to the band 2 by the connector 11, when the hemostatic device1 is attached to the wrist 500 in the state shown in FIG. 2, the balloon5 assumes a somewhat tilted orientation. As a result, the pressing forceF applied to the puncture site 510 acts in an oblique direction.

As shown in FIG. 1, the balloon 5 has connected thereto an inflator 7for introducing a fluid into the balloon 5. The inflator 7 is composedof a flexible tube 71 which is connected at a proximal end thereof tothe balloon 5 and which has a lumen that communicates with the interiorof the balloon 5, a bulb 72 which is provided at the distal end of thetube 71, and a tubular connector 73 which is joined to the bulb 72. Thetube 71 may include a connector or other means (not shown) which isconnected to the balloon 5 side thereof and adapted to allow the tube 71to be detached from the hemostatic device 1 of the present invention.

Inflation of the balloon 5 is carried out by inserting the protrudingtip of a syringe (not shown) into the connector 73 and pushing a plungeron the syringe so as to introduce fluid within the syringe through theinflator 7 into the balloon 5. Once fluid has been injected into theballoon 5 and the protruding tip of the syringe is withdrawn from theconnector 73, a check valve within the connector 73 closes, preventingthe fluid from leaking out and thus maintaining the balloon 5 in aninflated state.

As shown in FIG. 2, a secondary balloon 6 composed of a flexiblematerial may be provided between the curved plate 4 and theabove-described balloon 5 (sometimes referred to hereinafter as the“main balloon” to avoid confusion) in such a way that all or part of thesecondary balloon 6 overlaps with the main balloon 5. This secondaryballoon 6 functions as a pressing member for pressing against the mainballoon 5.

Under the pressure of the fluid with which it is filled, the secondaryballoon 6 applies to the main balloon 5 a pressing force (arrow f inFIG. 2) which is directed toward substantially the center 520 of thewrist 500. Under the influence of this pressing force f from thesecondary balloon 6, the main balloon 5 in turn applies to the puncturesite 510 a compressive force (arrow F in FIG. 2) that acts in an obliqueor inclined direction (toward the center 520 of the wrist 500) ratherthan vertically downward (that is, in a vertical direction with respectto the surface of the wrist 500). This arrangement provides a betterhemostatic effect and is thus able to more reliably stop bleeding thanwhen compression is applied to the puncture site 510 in a verticallydownward direction.

In the arrangement illustrated in FIG. 2 in which the hemostatic device1 is shown wrapped about the wrist 500, the main balloon 5 is not incontact with the curved plate 4 through the band 2. However, a portionof the main balloon 5 may be in contact with the curved plate 4 throughthe band 2.

The material making up the secondary balloon 6 is not subject to anyparticular limitation, as far as the puncture site 510 can be seentherethrough. For example, materials similar to the above-describedmaterials making up the band 2 and the main balloon 5 may be used. It ispreferable for the secondary balloon 6 to be substantially transparentto ensure that the puncture site 510 is externally visible. The materialmaking up the secondary balloon 6 is in the form of a sheet which mayhave a thickness like that of the material making up the main balloon 5.The secondary balloon 6 may also have a construction like that of themain balloon 5.

In the present embodiment of the invention, the secondary balloon 6 hasa smaller width in the lengthwise direction of the band 2 than the mainballoon 5. Hence, the secondary balloon 6 is smaller in size than themain balloon 5 and thus applies pressure locally to the main balloon 5.This enables the direction of the pressing force F applied by the mainballoon 5 to the puncture site 510 to be more reliably inclined.

Moreover, the secondary balloon 6 is positioned near the right end ofthe curved plate 4 in the lengthwise direction thereof, as shown in FIG.2. This enables the pressing force f applied by the secondary balloon 6to the main balloon 5 to be made more reliably directed toward thecenter 520 of the wrist 500. In turn, the direction of the pressingforce F applied by the main balloon 5 to the puncture site 510 can bemore reliably inclined.

In this embodiment, as mentioned above, the curved plate 4 has, on theside on which the main balloon 5 is positioned (the right side in FIG.2), a curved portion 42 with a radius of curvature smaller than that ofthe center portion 41 of the curved plate 4. The secondary balloon 6contacts, through the band 2, the curved portion 42 of the curved plate4 or a portion to the right side thereof in FIG. 2. In this way, thedirection of the force incurred by the secondary balloon 6 from thecurved plate 4, i.e., the normal direction of the curved plate 4 whereit contacts the secondary balloon 6 through the band 2, is inclinedtoward the center 520 of the wrist 500. As a result, the directions ofpressing force f and pressing force F can be more reliably inclined.

In this embodiment, a portion of the main balloon 5 and a portion of thesecondary balloon 6 are joined together by a suitable method such aswelding or adhesion. At the resulting junction, an opening 12 is formedas a means for communicating between the interior of the main balloon 5and the interior of the secondary balloon 6. When a fluid is injectedinto the main balloon 5 in the manner described above, some of theinjected fluid flows through the opening 12 into the secondary balloon6, so that the secondary balloon 6 inflates as the main balloon 5inflates. In this way, both balloons can be inflated in a singleoperation, providing excellent ease of use and efficiency.

In addition to being joined to the main balloon 5 in the vicinity of theopening 12, the secondary balloon 6 may also be joined to the mainballoon 5 at a place near the connector 11 (on the right end in FIG. 2).This enables pressure to be more reliably applied to the main balloon 5and increases the upward pushing force upon the curved plate 4, makingit easier to move the curved plate 4 away from the wrist 500.

In a different arrangement than that shown in FIGS. 1 and 2, inflationof the secondary balloon 6 by the introduction of a fluid may be carriedout separately from inflation of the main balloon 5.

Moreover, the secondary balloon 6 need not be adapted to inflate withthe injection of a fluid at the time of use as in the presentembodiment. Instead, it may be filled with a fluid and inflated to beginwith; that is, prior to the time of use.

In this invention, the pressing member which presses against the mainballoon 5 is not limited to a secondary balloon 6. Other types ofpressing members that may be used for this purpose include pads made ofa spongy substance, an elastomeric material, an assemblage of fiberssuch as cotton, or combinations thereof.

A method of using the above-described hemostatic device 1 of theinvention is described below.

(1) Before attaching the hemostatic device 1 to a patient's limb, themain balloon 5 and the secondary balloon 6 are placed in an uninflatedstate. In cases where the procedure is carried out at the wrist 500, thesite of puncture 510 into an artery is generally on the inner side ofthe wrist 500 (where the tendons are located) and on the thumb side.There will be times where an introducer sheath (not shown) is insertedand in place at the puncture site 510, and other times where no suchsheath is present. The method of using the inventive hemostatic device 1is the same in both cases. While compressing the puncture site 510 witha finger or other suitable means, the operator positions the mainballoon 5 over the puncture site 510, wraps the band 2 around the wrist500, and secures, or joins, the band 2 near both ends thereof with asurface fastener 3.

In a method of using the hemostatic device 110 according to thesubsequently described fourth embodiment of the invention, the operatortypically wraps the band 2 around a wrist 500 where an introducer sheathmay or may not be inserted and in place, positions the main balloon 5(band 2) so that a marker 8 provided on the balloon 5 lies over thepuncture site 510, and secures, or joins, the band 2 near both endsthereof with a surface fastener 3.

(2) Once the hemostatic device 1 has been attached to the wrist 500, asyringe (not shown) is connected to the connector 73 on the inflator 7and a fluid is introduced into the main balloon 5 and the secondaryballoon 6 as described above, thereby inflating the main balloon 5 andthe secondary balloon 6. In the present invention, the degree ofinflation by the main balloon 5 and the secondary balloon 6, i.e., thecompressive force applied to the puncture site 510, can easily beadjusted for the particular medical case and circumstances by varyingthe amount of fluid introduced at this time, making operation of thehemostatic device 1 very easy and efficient.

(3) Once the main balloon 5 and the secondary balloon 6 have beeninflated, the syringe is separated from the connector 73. If anintroducer sheath is in place at the puncture site 510, it is removed atthis point.

If the connector 73 has a check valve, the check valve is closed afterthe syringe is removed, which will prevent the sudden leakage of fluid.Thus, the main balloon 5 and the secondary balloon 6 remain inflated andso compression against the puncture site 510 is maintained (see FIG. 2).In this state, the main balloon 5 applies pressure locally to thepuncture site 510 and its environs. Moreover, inflation of the mainballoon 5 and the secondary balloon 6 causes the curved plate 4 to moveaway from the surface of the wrist 500 so that it does not readily comeinto contact with the wrist 500. Accordingly, compressive forces areconcentrated at the puncture site 510 and its environs, resulting in anexcellent hemostatic effect while avoiding the compression of othertissues, including blood vessels not requiring hemostatis and nerves,and thus effectively preventing undesirable effects such as numbness ofthe hand and poor circulation.

(4) In the fifth embodiment of the invention described later in thisspecification, after inflation of the main balloon 5 is complete, theinternal pressure of the balloon 5 gradually decreases. The internalpressure 60 minutes after inflation falls to about 20 to 70% of theinitial internal pressure. As a result, the compressive force applied tothe puncture site 510 eases over time, making it possible to prevent theharmful effects of a sustained compressive force, such as numbness,pain, and the occlusion of blood vessels (poor blood circulation).

(5) When bleeding is determined to have stopped to a sufficient degree,the hemostatic device 1 of the invention is removed from the puncturesite 510. The length of time from the completion of balloon 5 inflationuntil removal of the hemostatic device 1 (referred to hereinafter as the“hemostatic device attachment time”) is not subject to any particularlimitation. Hemostatis using this device may be carried out for a periodof, for example, 150 to 360 minutes. The hemostatic device attachmenttime may be selected as appropriate for the individual patient and hisor her medical condition.

Second to fifth embodiments of the inventive hemostatic device aredescribed below in conjunction with the attached drawings, withparticular reference to those features which differ from the foregoingfirst embodiment of the invention. Descriptions of like features areomitted.

Second Embodiment

FIG. 3 is a sectional view showing a hemostatic device according to asecond embodiment of the invention during use.

The hemostatic device 10 in this embodiment has the same features as thehemostatic device 1 in the above-described first embodiment, except thatthe secondary balloon 6 is connected to the band 2 via a flexibleconnector 13.

In the present embodiment, the secondary balloon 6, by being connectedto the band 2 via a connector 13 on the same side as the connector 11for the main balloon 5 (i.e., the right side in FIG. 3), more easily andreliably assumes a tilted orientation. This more readily allows thepressing force f applied to the main balloon 5 to act in an obliquedirection (that is, in a direction which causes the main balloon 5 toface substantially the center 520 of the wrist 500), thus enabling abetter hemostatic effect to be achieved.

Third Embodiment

FIG. 4 is a sectional view showing a hemostatic device according to athird embodiment of the invention during use.

The hemostatic device 100 in this embodiment has the same features asthe above-described first embodiment, except that it lacks a secondaryballoon 6.

That is, in the present embodiment, there is no secondary balloon 6.Instead, the main balloon 5 comes into contact with the curved plate 4through the band 2. Moreover, the balloon 5 is connected to the band 2only on one side through a connector 11, thus giving the balloon 5 asomewhat tilted orientation, as shown in FIG. 4. This enables thecompression force F applied to the puncture site 510 to act in anoblique direction (that is, in a direction facing the center 520 of thewrist 500). As in the first embodiment described above, the result isthat a better hemostatic effect can be obtained.

Moreover, as in the first embodiment, the balloon 5 is positioned on theconnector 11 side (the right side in FIG. 4) with respect to the curvedplate 4. The curved plate 4 has a center portion 41 and, on the side onwhich the balloon 5 is positioned (the right side in FIG. 4), a curvedportion 42 with a smaller radius of curvature than the center portion41. On the right side (in FIG. 4) of the curved portion 42, the curvedplate 4 pushes the balloon 5 (through the intervening band 2) in adirection facing the center portion 520 of the wrist 500. Hence, in thisembodiment, the compressive force F acts more reliably in an obliquedirection.

Fourth Embodiment

FIG. 5 is a bottom view of a fourth embodiment of the hemostatic deviceof the invention. This shows the side of the device that serves as theinside surface when the device is attached to the wrist of a patient.FIG. 6 is a sectional view showing the same hemostatic device as in FIG.5 when attached and in use on the wrist of a patient.

As shown in FIG. 5, the hemostatic device 110 of the present embodimenthas a marker 8 provided on the inside surface of the main balloon 5;that is, the surface which comes into contact with the puncture site 510(the front side in the plane of FIG. 5). Providing such a marker 8 onthe balloon 5 in the hemostatic device 110 of this embodimentfacilitates proper positioning of the balloon 5 at the puncture site510, which in turn helps prevent blood leakage and hematoma formationdue to poor positioning of the balloon 5.

As shown in FIG. 5, it is preferable for the marker 8 to be provided atthe center of the balloon 5; that is, to be centered at the intersectionof the diagonals for the square shape of the balloon 5. Because thisenables the center of the balloon 5 to be properly positioned at thepuncture site 510, when the balloon 5 has been inflated, the compressiveforce applied by the balloon 5 acts reliably upon the puncture site 510.

The marker 8 is not limited to any particular shape. Examples ofsuitable shapes include circular, triangular and square shapes. In FIG.5, the marker 8 has a square shape.

No particular limitation is imposed on the size of the marker 8.However, when the marker 8 is square, for example, it is preferable forthe length of one side of the square to be in a range of 1 to 4 mm. Ifthe length of one side is 5 mm or more, the marker 8 becomes largerelative to the size of the puncture site 510, which may make the centerof the balloon 5 difficult to position properly over the puncture site510.

The marker 8 may be made of any suitable material, including oil-basedcoloring materials such as inks, and pigment-containing resins.

The color of the marker 8 is not subject to any particular limitation,insofar as it is a color that enables the balloon 5 to be properlypositioned at the puncture site 510. However, a greenish color ispreferred because this makes the marker 8 readily visible on blood andthe skin, thus enabling the balloon 5 to be more easily positioned atthe puncture site 510.

It is also desirable for the marker 8 to be translucent so as to enablethe puncture site 510 to be visible from outside of the marker 8.

No particular limitation is imposed on the method used to place themarker 8 on the balloon 5. Examples of suitable methods include printingthe marker 8 onto the balloon 5, welding the marker 8 to the balloon 5,and applying an adhesive to one side of the marker 8 and affixing it tothe balloon 5.

It is also possible to place the marker 8 on the outside surface of theballoon 5; that is, on the side opposite the surface of the balloon 5that comes into direct contact with the puncture site 510 (the back sidein the plane of FIG. 5).

Alternatively, instead of being placed on the main balloon 5, the marker8 may be placed on the band 2, on the curved plate 4, or on thesubsequently described secondary balloon 6. In such cases, it isadvantageous for the marker 8 to be placed in such a way that it can bepositioned over the center of the main balloon 5.

In the hemostatic device 110 of the present embodiment, the band 2should be made of a material which allows the puncture site 510 to beseen. Those materials mentioned earlier in connection with the band inthe first embodiment of the hemostatic device are widely used for thematerial of the band 2 in this embodiment. Further, it is preferable forthe band 2 to be substantially transparent so that the puncture site 510can be reliably seen from the outside and the marker 8 can be easily andproperly positioned at the puncture site 510.

In the hemostatic device 110 of this embodiment, the curved plate 4should be made of a material which allows the puncture site 510 to beseen. Those materials mentioned earlier in connection with the curvedplate in the first embodiment of the hemostatic device are widely usedfor the material of the curved plate 4 in this embodiment. Further, itis preferable for the curved plate 4 in the present embodiment to besubstantially transparent so that the puncture site 510 is reliablyvisible from the outside and the marker 8 can be easily and properlypositioned at the puncture site 510.

In the hemostatic device 110 of this embodiment, the main balloon 5should be made of a material which allows the puncture site 510 to beseen. Those materials mentioned earlier in connection with the mainballoon in the first embodiment of the hemostatic device are widely usedfor the material of the main balloon 5 in this embodiment. Further, itis desirable for the main balloon 5 to be substantially transparent sothat the puncture site 510 is reliably visible from the outside and themarker 8 can be easily and properly positioned at the puncture site 510.

In the hemostatic device 110 of this embodiment, the second balloon 6should be made of a material which allows the puncture site 510 to beseen. Those materials mentioned earlier in connection with the secondballoon in the first embodiment of the hemostatic device are widely usedfor the material of the second balloon 6 in this embodiment. Further, itis preferable for the secondary balloon 6 to be substantiallytransparent so that the puncture site 510 is reliably visible from theoutside and the marker 8 can be easily and properly positioned at thepuncture site 510. By adopting an arrangement in which, as shown in FIG.6, the secondary balloon 6 is connected to the band 2 through aconnector 13 on the same side (the right side in FIG. 6) as theconnector 11 for the main balloon 5, the same effect can be achieved asin the second embodiment described earlier.

Fifth Embodiment

In the hemostatic device of the present embodiment, the balloon 5 isconstructed so that, following complete inflation thereof, the internalpressure decreases over time, the internal pressure 60 minutes afterinflation becoming 20 to 70%, and preferably 30 to 60%, of the initialinternal pressure. Here, “initial internal pressure” refers to thepressure within the balloon 5 ten seconds after inflation is complete;that is, after the balloon 5 has been inflated to a degree sufficient toachieve a compressive force suitable to stop bleeding.

By means of such an arrangement, the compressive force applied by theballoon 5 relaxes suitably (neither too much nor too little) with thepassage of time, making it possible to effectively prevent the harmfuleffects of a sustained compressive force, such as numbness, pain andvascular blockage (poor circulation) at the puncture site 510 and areasperipheral thereto. In particular, the decrease in the internal pressureof the balloon 5 occurs spontaneously without requiring some sort ofmanual operation (such as the loosening of a valve to reduce pressure orrelease gas) by a physician, nurse or other health care practitioner.This makes it possible to avoid the trouble and inconvenience associatedwith such operations.

If the internal pressure 60 minutes after balloon inflation exceeds 70%of the initial internal pressure, the compressive force (internalpressure) at the time of inflation of the balloon 5 remains atsubstantially the same level. There may be situations in which it may bedesirable to avoid such a case.

On the other hand, if the internal pressure 60 minutes after ballooninflation is less than 20% of the initial internal pressure, the percentdecrease in the internal pressure of the balloon 5 may be more thandesired. There may be situations in which such decrease in the internalballoon pressure causes the compressive force of the balloon 5 todiminish before sufficient hemostasis has occurred, which may result inblood leakage at the puncture site 510.

Specific arrangements for lowering the internal pressure of the balloon5 over time in the manner described above are given below.

A. Make the band 2 and/or the balloon 5 of a material which is flexibleand easily deformed (extended).

The band 2 and/or balloon 5 gradually deform under the internal pressureand resilience of the inflated balloon 5 so as to conform to the shapeof the puncture site 510. As a result, the internal pressure of theballoon 5 decreases, easing the compressive force applied to thepuncture site 510. That is, the decrease in the compressive force actingupon the puncture site 510 is controlled by the physical properties(tensile modulus, thickness, elongation percentage, etc.) of thematerials making up the band 2 and/or balloon 5.

Specifically, the band 2 has a tensile modulus of preferably not morethan 10 gf/mm², and most preferably 2 to 9 gf/mm².

The band 2 wrapped around the wrist 500 has an elongation percentage 180minutes after balloon inflation of preferably 1 to 7%, and morepreferably 3 to 6%.

B. Control the gas permeability of the balloon 5. This enables gaswithin the balloon 5 to pass through the sheet material making up theballoon 5 and be slowly released to the exterior. As a result, theinternal pressure of the balloon 5 gradually decreases, easing thecompressive force applied to the puncture site 510.

C. Control the gas permeability of the secondary balloon 6 whichcommunicates with the main balloon 5. The gas within the secondaryballoon 6 passes through the sheet material of which the secondaryballoon 6 is made and is gradually released to the exterior. This bringsabout a gradual decline in the internal pressure of both the secondaryballoon 6 and also the main balloon 5 that communicates with it, easingthe compressive force applied to the puncture site 510.

D. Control the gas permeability of the tube 71 which communicates withthe balloon 5 and/or the bulb 72. In this way, the gas within theballoon 5 passes through the tube 71 and/or bulb 72 and is slowlyreleased to the exterior, allowing the internal pressure of the balloon5 to gradually decrease and thus easing the compressive force applied tothe puncture site 510.

E. Make the gas backflow-preventing effect of the check valve within theconnector 73 incomplete so that a small amount of gas leaks out throughthe check valve. As a result, a small amount of gas within the balloon 5is steadily discharged to the exterior through the check valve withinthe connector 73, gradually lowering the internal pressure of theballoon 5 and easing the compressive force applied to the puncture site510.

F. Combinations of any two or more of above arrangements A to E.

Methods A to F above have the advantage of enabling control of theinterior pressure within the balloon 5 (i.e., pressure reduction overtime) to be achieved with a simple arrangement. Method A in particularenables the interior pressure of the balloon 5 to be controlled bysuitable selection of the constituent materials and dimensions of theband 2 and the balloon 5.

In the hemostatic device of the present embodiment, the internalpressure of the balloon 5 gradually decreases shortly after inflationhas been completed. The internal pressure 60 minutes after dilationfalls to about 20 to 70% of the initial internal pressure. This easesthe compressive force applied to the puncture site 510, making itpossible to prevent various harmful effects due to the sustainedapplication of a compressive force, such as numbness, pain and vascularblockage (poor circulation).

Once it is determined that sufficient hemostasis has been achieved, thehemostatic device is removed from the puncture site 510. The time untilremoval of the hemostatic device following complete inflation of theballoon (i.e., the hemostatic device attachment time) is not subject toany particular limitation, although removal is typically carried outafter about 150 to 360 minutes. This hemostatic device attachment timecan be selected as appropriate for the particular patient and his or hercondition.

EXAMPLES

Examples of the invention and comparative examples are given below byway of illustration and not by way of limitation.

Example 1

A main balloon and a secondary balloon were each fabricated from asubstantially transparent polyvinyl chloride sheet having a tensilemodulus of 8 gf/mm² and a thickness of 0.3 mm. In addition, a band wasfabricated from a substantially transparent polyvinyl chloride sheetalso having a tensile modulus of 8 gf/mm² and a thickness of 0.3 mm. Theband had a length of 190 mm and a width of 40 mm. The main balloon,secondary balloon and band were welded together at the necessary placesto form a hemostatic device according to the fifth embodiment of theinvention having the construction shown in FIG. 1. A curved plate madeof substantially transparent polycarbonate resin and curved at both endswas inserted into a curved plate holder on the band.

This hemostatic device was wrapped around the wrist and the balloon wasinflated by injecting air into the balloon through the connector 73 onthe inflator 7 until the balloon internal pressure reached about 150mmHg. Next, the internal pressure of the balloon was measured, first 10seconds after full inflation of the balloon (initial internal pressure),then 10, 30, 60, 120 and 180 minutes after full inflation. The resultsof measurement are shown in Table 1 below and FIG. 7.

In addition, 180 minutes after inflation, the hemostatic device wasremoved from the wrist and the length of the band was measured. The bandhad a length of 197 mm, representing an elongation percentage of 3.6%.

TABLE 1 Example 1 Internal Pressure as a pressure percentage of Timeelapsed after of balloon initial internal balloon inflation (mmHg)pressure  10 seconds 161 100  10 minutes 128 79.5  30 minutes 108 67.0 60 minutes 79 49.0 120 minutes 66 40.9 180 minutes 64 39.7

Example 2

A main balloon and a secondary balloon were each fabricated from asubstantially transparent polyvinyl chloride sheet material having atensile modulus of 3 gf/mm² and a thickness of 0.2 mm. In addition, aband was fabricated from a substantially transparent polyvinyl chloridesheet material also having a tensile modulus of 3 gf/mm² and a thicknessof 0.2 mm. The band had a length of 190 mm and a width of 40 mm. Themain balloon, secondary balloon and band were welded together at thenecessary places to form a hemostatic device according to the fifthembodiment of the invention having the construction shown in FIG. 1. Acurved plate made of substantially transparent polycarbonate resin andcurved at both ends was inserted into a curved plate holder on the band.

This hemostatic device was wrapped around the wrist and the balloon wasinflated by injecting air into the balloon through the connector 73 onthe inflator 7 until the balloon internal pressure reached about 150mmHg. Next, the internal pressure of the balloon was measured, first 10seconds after full inflation of the balloon (initial internal pressure),then 10, 30, 60, 120 and 180 minutes after full inflation. The resultsof measurement are shown in Table 2 below and FIG. 7.

In addition, 180 minutes after inflation, the hemostatic device wasremoved from the wrist and the length of the band was measured. The bandhad a length of 201 mm, representing an elongation percentage of 5.8%.

TABLE 2 Example 2 Internal Pressure as a pressure percentage of Timeelapsed after of balloon initial internal balloon inflation (mmHg)pressure  10 seconds 152 100  10 minutes 133 87.5  30 minutes 110 72.4 60 minutes 84 55.2 120 minutes 59 38.8 180 minutes 40 26.3

Comparative Example 1

A main balloon and a secondary balloon were each fabricated from asubstantially transparent polyvinyl chloride sheet material having atensile modulus of 16 gf/mm² and a thickness of 0.3 mm. In addition, aband was fabricated from a substantially transparent polyvinyl chloridesheet material having a tensile modulus of 17 gf/mm² and a thickness of0.5 mm. The band had a length of 190 mm and a width of 40 mm. The mainballoon, secondary balloon and band were welded together at thenecessary places to form a hemostatic device having the constructionshown in FIG. 1. A curved plate made of substantially transparentpolycarbonate resin and curved at both ends was inserted into a curvedplate holder on the band.

This hemostatic device was wrapped around the wrist and the balloon wasinflated by injecting air into the balloon through the connector 73 onthe inflator 7 until the balloon internal pressure reached about 150mmHg. Next, the internal pressure of the balloon was measured, first 10seconds after full inflation of the balloon (initial internal pressure),then 10, 30, 60, 120 and 180 minutes after full inflation. The resultsof measurement are shown in Table 3 below and FIG. 7.

In addition, 180 minutes after inflation, the hemostatic device wasremoved from the wrist and the length of the band was measured. The bandhad a length of 191 mm, representing an elongation percentage of 0.5%.

TABLE 3 Comparative Example 1 Internal Pressure as a pressure percentageof Time elapsed after of balloon initial internal balloon inflation(mmHg) pressure  10 seconds 155 100  10 minutes 131 84.5  30 minutes 12278.7  60 minutes 113 73.9 120 minutes 108 69.6 180 minutes 106 68.3

Comparative Example 2

A hemostatic device manufactured by Nippon Sherwood Medical IndustriesLtd. under the trade name Radiseal was furnished for use. In thishemostatic device, the band was composed of a polyvinyl chloride sheethaving a thickness of about 0.5 mm and the balloon was composed of apolyvinyl chloride sheet having a thickness of about 0.3 mm.

The device lacked a secondary balloon and was constructed such that,when inflated, the balloon pressed against substantially the center ofthe wrist.

This hemostatic device was wrapped around the wrist and the balloon wasinflated by introducing air from an inflator until the balloon internalpressure reached about 150 mmHg. Next, the internal pressure of theballoon was measured, first 10 seconds after full inflation of theballoon (initial internal pressure), then 10, 30, 60, 120 and 180minutes after full inflation. The results of measurement are shown inTable 4 below and FIG. 7.

TABLE 4 Comparative Example 2 Internal Pressure as a pressure percentageof Time elapsed after of balloon initial internal balloon inflation(mmHg) pressure  10 seconds 153 100  10 minutes 136 88.8  30 minutes 13084.9  60 minutes 125 81.6 120 minutes 117 76.4 180 minutes 113 73.8

Comparative Example 3

A main balloon and a secondary balloon were each fabricated from asubstantially transparent polyvinyl chloride sheet material having atensile modulus of 16 gf/mm² and a thickness of 0.3 mm. In addition, aband was fabricated from a substantially transparent polyvinyl chloridesheet material having a tensile modulus of 17 gf/mm² and a thickness of0.5 mm. The band had a length of 190 mm and a width of 40 mm. The mainballoon, secondary balloon and band were welded together at thenecessary places. In addition, the sheet material making up thesecondary balloon was pierced in three places with a needle to formsmall holes and thereby increase the gas permeability of the secondaryballoon. This yielded a hemostatic device having the construction shownin FIG. 1. A curved plate made of substantially transparentpolycarbonate resin and curved at both ends was inserted into a curvedplate holder on the band.

This hemostatic device was wrapped around the wrist and the balloon wasinflated by injecting air into the balloon through the connector 73 onthe inflator 7 until the balloon internal pressure reached about 150mmHg. Next, the internal pressure of the balloon was measured, first 10seconds after full inflation of the balloon (initial internal pressure),then 10, 30, 60, 120 and 180 minutes after full inflation. The resultsof measurement are shown in Table 5 below and FIG. 7.

TABLE 5 Comparative Example 3 Internal Pressure as a pressure percentageof Time elapsed after of balloon initial internal balloon inflation(mmHg) pressure  10 seconds 154 100  10 minutes 107 69.5  30 minutes 5636.4  60 minutes 27 17.5 120 minutes 15 9.7 180 minutes 6 3.9

In both Examples 1 and 2 according to the invention, no numbness, painor poor circulation arose in the wrist or areas peripheral thereto, suchas the palm and fingers, when the hemostatic device was attached or evenlater when the hemostatic device was removed from the wrist 180 minutesafter inflation of the balloon.

By contrast, in Comparative Examples 1 and 2, some numbness of thefingers was sensed when the hemostatic device was attached and when thehemostatic device was removed from the wrist 120 minutes or 180 minutesafter inflation of the balloon.

In Comparative Example 3, a sense of pressure by the balloon at thewrist ceased almost entirely to be felt 30 to 60 minutes after ballooninflation. The hemostatic effects were thus presumably insufficient inthis case.

The illustrated embodiments of the hemostatic device of the inventionhave been described above, although many modifications and variationsmay be made thereto in light of the above teachings. It is therefore tobe understood that the invention may be practiced otherwise than asspecifically described without departing from the scope of the appendedclaims. For example, various parts of the hemostatic device having thespecific configurations shown and described herein may be substitutedwith parts of similar function but having other configurations.Moreover, other suitable components may be added to the hemostaticdevice as described herein.

The hemostatic device of the invention is not limited to use on thewrist alone, and can be employed as a hemostatic device for attachmentand use on any portion of a patient's arm or leg (referred tocollectively in this specification as “limbs”).

As described above and demonstrated in the examples, the hemostaticdevice of the invention provides excellent hemostatic effects andmoreover prevents harmful effects such as numbness and poor circulationin areas peripheral to the site of attachment thereof.

An even better hemostatic effect can be obtained when the balloon is ina position deviated to one end of the curved plate in the lengthwisedirection of the band, and especially when the curved plate has, on theside on which the balloon is positioned, a portion with a smaller radiusof curvature than the center portion of the curved plate.

By providing a marker for positioning the balloon at the site wherebleeding is to be stopped, the balloon can easily be properly positionedand blood leakage or hematoma formation due to incorrect placement ofthe balloon can be prevented.

In embodiments of the inventive hemostatic device in which the internalpressure of the inflated balloon decreases over time, the compressiveforce applied by the balloon relaxes suitably (neither too much nor toolittle) with the passage of time, enabling the effective prevention ofharm from a sustained compressive force, such as numbness, pain orvascular blockage (poor circulation) at the puncture site and areasperipheral thereto.

In such embodiments, the decrease in the internal pressure of theballoon occurs spontaneously without requiring some sort of manualoperation (such as the loosening of a valve to reduce pressure orrelease gas) by a physician, nurse or other health care practitioner.This makes it possible to avoid the trouble and inconvenience associatedwith such operations.

What is claimed is:
 1. A hemostatic device comprising: a flexible bandconfigured to be wrapped around a wrist of a patient at a site wherebleeding is to be stopped so that the flexible band is in a wrappedstate on the patient's wrist; a fastener to secure the flexible band inthe wrapped state around the patient's wrist; a curved plate possessingan inner surface and an outer surface, the curved plate defining aconcave curve along the inner surface; a balloon positionable betweenthe curved plate and the patient's wrist in the wrapped state of theflexible band, the balloon including a center, the balloon beinginflatable upon introducing gas into the balloon when the flexible bandis in the wrapped state with the balloon positioned between thepatient's wrist and the plate to apply a compressive force to the sitewhere bleeding is to be stopped; a marker located to position the centerof the balloon at the site where bleeding is to be stopped; the band,the balloon and the curved plate being fabricated from substantiallytransparent materials permitting visualization of the site wherebleeding is to be stopped when the flexible band is in the wrapped statewith the balloon positioned between the patient's wrist and the curvedplate; and the balloon being made of a gas permeable material selectedso that after the balloon is inflated by the gas, the gas in the balloonis gradually released through the gas permeable material to outside theballoon to gradually decrease the compressive force applied to the sitewhere bleeding is to be stopped.
 2. The hemostatic device according toclaim 1, wherein the gas permeable material from which the balloon isfabricated is a gas permeable material that allows release of the gasthrough the gas permeable material to the outside of the balloon so thatan internal pressure in the balloon 60 minutes after inflation of theballoon to an initial internal pressure is equal to or less than 70% ofthe initial internal pressure and is equal to or greater than 20% of theinitial internal pressure, the initial internal pressure being theinternal pressure in the balloon ten seconds after the balloon isinflated to a degree sufficient to produce a compressive force to stopbleeding.
 3. The hemostatic device according to claim 1, wherein the gaspermeable material from which the balloon is fabricated is a gaspermeable material that allows release of the gas through the gaspermeable material to the outside of the balloon so that an internalpressure in the balloon 60 minutes after inflation of the balloon to aninitial internal pressure is less than the initial internal pressure andis equal to or greater than 20% of the initial internal pressure, theinitial internal pressure being the internal pressure in the balloon tenseconds after the balloon is inflated to a degree sufficient to producea compressive force to stop bleeding.
 4. The hemostatic device accordingto claim 1, wherein the balloon is a first balloon, further comprising asecond balloon positionable between the curved plate and the patient'swrist in the wrapped state of the flexible band.
 5. The hemostaticdevice according to claim 1, wherein the second balloon is inflatable toan initial internal pressure is a different size than the first balloonpositionable between the curved plate and the first balloon in thewrapped state of the flexible band.
 6. The hemostatic device accordingto claim 1, further comprising a connector connecting the balloon to theflexible band.
 7. A hemostatic device comprising: a band made offlexible material allowing the band to be wrapped around a wrist of apatient at a site where bleeding is to be stopped so that the band is ina wrapped state on the patient's wrist; a fastener to secure theflexible band in the wrapped state around the patient's wrist; a platepossessing an inner surface and an outer surface, at least a portion ofthe plate being curved so that the plate includes a curved plateportion, the curved plate portion defining a concave curve along theinner surface of the plate that faces toward the patient when the bandis in the wrapped state; a balloon positionable between the plate andthe patient's wrist when the band is in the wrapped state, the balloonbeing inflatable upon introducing gas into the balloon when the band isin the wrapped state with the balloon positioned between the patient'swrist and the plate to apply a compressive force to the site wherebleeding is to be stopped; the band, the balloon and at least a part ofthe plate being substantially transparent to permit visualizationthrough the band, the plate and the balloon of the site where bleedingis to be stopped when the band is in the wrapped state with the balloonpositioned between the patient's wrist and the plate; and the balloonbeing made of a material which is permeable to the gas in the balloonafter the gas is introduced into the balloon to inflate the balloon andwhich is selected so that the gas in the balloon is gradually releasedthrough the gas permeable material to outside the balloon to graduallydecrease the compressive force applied to the site where bleeding is tobe stopped.
 8. The hemostatic device according to claim 7, wherein thematerial from which the balloon is fabricated is a gas permeablematerial that allows release of the gas through the gas permeablematerial to the outside of the balloon so that an internal pressure inthe balloon 60 minutes after inflation of the balloon to an initialinternal pressure is equal to or less than 70% of the initial internalpressure and is equal to or greater than 20% of the initial internalpressure, the initial internal pressure being the internal pressure inthe balloon ten seconds after the balloon is inflated to a degreesufficient to produce a compressive force to stop bleeding.
 9. Thehemostatic device according to claim 7, wherein the material from whichthe balloon is fabricated is a gas permeable material that allowsrelease of the gas through the gas permeable material to the outside ofthe balloon so that an internal pressure in the balloon 60 minutes afterinflation of the balloon to an initial internal pressure is less thanthe initial internal pressure and is equal to or greater than 20% of theinitial internal pressure, the initial internal pressure being theinternal pressure in the balloon ten seconds after the balloon isinflated to a degree sufficient to produce a compressive force to stopbleeding.
 10. The hemostatic device according to claim 7, furthercomprising a marker on the balloon to facilitate positioning of theballoon at the site where bleeding is to be stopped.
 11. The hemostaticdevice according to claim 11, further comprising a marker on the band tofacilitate positioning of the balloon at the site where bleeding is tobe stopped.
 12. The hemostatic device according to claim 7, furthercomprising a marker on the plate balloon to facilitate positioning ofthe balloon at the site where bleeding is to be stopped.
 13. Thehemostatic device according to claim 7, wherein the balloon is a firstballoon, and further comprising a second balloon positionable betweenthe plate and the patient's wrist when the band is in the wrapped state.14. The hemostatic device according to claim 7, wherein the secondballoon is inflatable and is smaller in size than the first balloon wheninitially inflated for use.
 15. The hemostatic device according to claim7, further comprising a connector connecting the balloon to the flexibleband.
 16. A method to stop bleeding at a puncture site of an artery on awrist of a patient, the method comprising: wrapping a band of ahemostatic device around the wrist of the patient, the hemostatic devicealso comprising a plate that includes a portion which is curved, aballoon and a marker, the flexible band, the curved plate and theballoon being substantially transparent; the wrapping of the band aroundthe wrist of the patient comprising wrapping the band around the wristof the patient while the balloon is in an uninflated state so that theballoon is between the plate and the wrist of the patient; positioningthe balloon in overlying relation to the puncture site, the positioningof the balloon in overlying relation to the puncture site beingaccomplished by visually observing the marker; introducing fluid intothe balloon to increase internal pressure in the balloon and inflate theballoon to apply a compressive force to the puncture site selected tostop bleeding at the puncture site; after inflating the balloon to applythe compressive force to the puncture site to help stop bleeding at thepuncture site, gradually decreasing the internal pressure in the balloonwhile maintaining the compressive force against the puncture site; andthe gradual decrease of the internal pressure in the balloon beingperformed without any manual operation.
 17. The method according toclaim 16, wherein the gradual decrease of the internal pressure in theballoon includes gradually decreasing the internal pressure in theballoon so that the internal pressure in the balloon 60 minutes afterinflation of the balloon to an initial internal pressure is less thanthe initial internal pressure and is equal to or greater than 20% of theinitial internal pressure, the initial internal pressure being theinternal pressure in the balloon ten seconds after the balloon isinflated to a degree sufficient to produce the compressive force to stopbleeding.
 18. The method according to claim 16, wherein the gradualdecrease of the internal pressure in the balloon includes graduallydecreasing the internal pressure in the balloon so that the internalpressure in the balloon 60 minutes after inflation of the balloon to aninitial internal pressure is equal to or less than 70% of the initialinternal pressure and is equal to or greater than 20% of the initialinternal pressure, the initial internal pressure being the internalpressure in the balloon ten seconds after the balloon is inflated to adegree sufficient to produce the compressive force to stop bleeding. 19.The method according to claim 16, wherein the balloon includes a center,and the positioning of the balloon in overlying relation to the puncturesite includes positioning the center of the balloon above the puncturesite.